To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL

Part 1: This is a 5 Arm study primarily to determine the best dose out of the two dose levels of Belinostat and Pralatrexate combined with CHOP/COP in newly diagnosed PTCL patients based on Safety for part 2 study. Part 2 (Efficacy and Safety): This is a 3 Arm study. Patients with previously untreated PTCL will be randomized 1:1:1 into 1 of 3 treatment groups: 2 experimental treatment groups (Bel-CHOP or Fol-COP) or 1 active comparator treatment group (CHOP). Patients will be treated for up to 6 cycles. The primary objective is to compare the Progression Free Survival of patients with newly d

Trial Details

NCT ID
NCT06072131
Phase
PHASE3
Sponsor
Acrotech Biopharma Inc.
Status
RECRUITING
Cancer Type
Non-Hodgkin Lymphoma Lymphoma
Interventions
  • Belinostat Injection
  • Pralatrexate Injection
  • CHOP
  • COP
Locations (sample)
  • Clovis, California, United States|36.82523,-119.70292
  • Santa Monica, California, United States|34.01949,-118.49138
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Pembroke Pines, Florida, United States|26.00315,-80.22394
  • Louisville, Kentucky, United States|38.25424,-85.75941

Key Eligibility Criteria

  • Patient with newly diagnosed, untreated histology-proven PTCL based on local pathology review who is eligible for receiving, Belinostat, Pralatrexa…
  • Pathology subtype:
  • Peripheral T-cell lymphoma, not otherwise specified
  • Angioimmunoblastic T-cell lymphoma

For full eligibility, visit ClinicalTrials.gov.

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